Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06410651

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma

Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) who failed to induction chemo(immuno)therapy had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc.

Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies.

The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and S-1 and concurrent radiotherapy for patients who are not sensitive to induction chemo(immuno)therapy.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Location status: Recruiting

Location contact

Xin Wang, doctor

CONTACT

[email protected]

13311583220

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed esophageal squamous cell carcinoma. Tumor response was evaluated as stable or locoregionally progresive disease or assessed by surgeons being unresectable (without distant metastasis) after induction chemo(immuno)therapy.
  • Cycles of induction chemo(immuno)therapy was 2-4.
  • KPS score ≥70.
  • Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;

Exclusion criteria

  • Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
  • There are active infections, such as active tuberculosis and hepatitis
  • There are contraindications to targeted therapy.

Treatment and study plan

Nimotuzumab with chemoradiotherapy

Combination Product

Radiotherapy, 40-50.4Gy/20-28f. Nimotuzumab 400mg, ivgtt, W2d. Chemotherapy, S-1, 40-60mg/m2, on BSA,orally twice daily on radiotherapy days.

Primary outcomes

  1. R0 resection rate

    Time frame: 4 months after initiation of induction chemoimmunotherapy

    Minimal distance tumor/circumferential resection margin (CRM) > 1 mm.

Secondary outcomes

  1. Pathological complete response

    Time frame: 4 months after initiation of induction chemoimmunotherapy

    the complete remission of all viable cancer cells in any of the specimens from surgery, including the primary site and lymph nodes

  2. Event-free survival

    Time frame: 1 year after all treatment

    the time from start of induction chemo(immuno)therapy to progression, relapse, all-cause death, or the last day of follow-up

  3. Side effects during chemoradiotherpay

    Time frame: 1 month after chemoradiotherapy

    the time from start of chemoradiotherapy to 1 month after chemoradiotherapy

  4. Postoperative complications

    Time frame: 1 month after surgery

  5. Overall survival

    Time frame: 1 year after all treatment

    the time from start of induction chemo(immuno)therapy to all-cause death, or the last day of follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Guojie Feng, B.M

CONTACT

[email protected]

16601212285

Xin Wang, doctor

CONTACT

[email protected]

13311583220

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma After Failure of Chemotherapy:A Phase II Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 13, 2024
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.